The Effect of Music Therapy in COVID-19 Patients Given Prone Position
Primary Purpose
Music Therapy, Anxiety, Respiratory Distress Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
musıc therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Music Therapy focused on measuring COVID-19, Prone position
Eligibility Criteria
Inclusion Criteria:
- Adult patients between the ages of 18-80
- Developing respiratory failure due to COVID-19
- Prone position applied
- Staying in intensive care unit for at least 24 hours
- Awake and cooperative
- Recipient of oxygen mask or high-flow oxygen therapy or noninvasive mechanical ventilation support
- Stable hemodynamic status
Exclusion Criteria:
- Those who do not agree to participate in the research
- Those with communication barrier problems
- Intubated
- Sedation drug applied
- Those who need emergency intervention during work
- Having a diagnosis of neurological and psychological medicine
- Abnormal deterioration in physiological parameters
- Patients transferred to another service or discharged
- patients with hearing impairment
Sites / Locations
- Antalya Kepez State Hospital Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
music therapy
control
Arm Description
Music therapy intervention, bluetooth headphones will be applied in the intensive care unit and will be disinfected after the application. The intervention consists of a 30-minute, single-session, nature-based music concert. the music concert is calibrated by the audiologist (60 decibels). During nature-based music listening, patients will be asked to close their eyes, rest and follow the sound flow.
The control group will be given the prone position and music therapy will not be applied.
Outcomes
Primary Outcome Measures
anxiety
State Anxiety Inventory
vital signs
pulse rate
vital signs
respiratory rate
vital signs
blood pressure
vital signs
oxygen saturation
prone position adaptation
length of stay in prone position
Secondary Outcome Measures
Full Information
NCT ID
NCT05038514
First Posted
September 5, 2021
Last Updated
April 24, 2022
Sponsor
Kutahya Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT05038514
Brief Title
The Effect of Music Therapy in COVID-19 Patients Given Prone Position
Official Title
The Effect of Music Therapy on Adaptation and Anxiety Levels in COVID-19 Patients Given Prone Position: A Triple-blind Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Almost half of the patients diagnosed with COVID-19 pneumonia develop ARDS and most of these patients are treated in the intensive care unit. In the management of COVID-19 ARDS, prone position is applied to improve physiological parameters by facilitating better distribution of tidal volume and drainage of secretions. It has been reported that awake patients in COVID clinics could not adapt their prone position due to anxiety . Jiang et al (2020) reported that awake patients may not tolerate the prone position and may experience anxiety due to posture habits and discomfort.
It was determined that anxiety developed on the second day of hospitalization in the intensive care unit, state anxiety was associated with trait anxiety and pain, and anxiety was low in patients receiving mental health care/treatment . And also not to change position himself of patient in prone position due to care equipment etc it can cause loss of self-control and anxiety. Twelve-sixteen hour prone position recommendation for clinical improvement, positioning difficulties in patients who cannot position themselves may also trigger anxiety in awake patients It has been suggested that music therapy may be effective in reducing anxiety related to weaning from mechanical ventilation in COVID-19 patients. Music therapy intervention in ICU has been tested in sessions of at least 30 minutes, 1-30 days, with options such as western music, classical Chinese music, nature-based music. In the study of Chu and Zhang (2021), it was shown that the recovery time for tomography findings, the number of days of hospital stay and the rates of transfer to the intensive care unit were lower in the patient group who received holistic mode including traditional Chinese medicine, music therapy, and emotional support in COVID-19 patients. Studies evaluating the effectiveness of music therapy alone in the COVID-19 intensive care process could not be reached. It is thought that music therapy applied in the prone position in the COVID-19 intensive care unit will reduce the anxiety of the patients, adapt to the prone position and improve their clinical parameters.
Detailed Description
The Corona virus disease 2019 Pandemic (COVID-19) has caused a psychosocial depression in the world. Acute severe or critical condition has been observed in 20% of individuals diagnosed with COVID-19. It is stated that viral pneumonia or Acute Respiratory Distress Syndrome (ARDS) and organ failures develop in these individuals. Almost half of the patients diagnosed with COVID-19 pneumonia develop ARDS and most of these patients are treated in the intensive care unit. In the management of COVID-19 ARDS, prone position is applied to improve physiological parameters by facilitating better distribution of tidal volume and drainage of secretions. It is thought that the prone position will be more effective in the early stages of the disease and awake patients. It is recommended that the prone position especially in moderate to severe ARDS cases be applied for at least 12 hours after symptoms stabilize. Elkattawy and Noori (2020) reported that at least 6-8 hours of prone position improves oxygenation in the COVID-19 case without ARDS criteria. Mac Sweeney et al. (2020) reported that clinical parameters improved, intubation and ventilator requirement were delayed in an awake, self-prone COVID-19 case. However, Somagutta et al (2021) reported anxiety, back pain, adjustment and tolerance problems in awake and not mechanically ventilated patients. Bastoni et al, in the study which they evaluated prone adapt at emergency department in Italy; it is reported positioning could not be maintained in four out of ten patients due to unconformity, pain, and rejection of prone position. It has been reported that awake patients in COVID clinics could not adapt their prone position due to anxiety. Jiang et al (2020) reported that awake patients may not tolerate the prone position and may experience anxiety due to posture habits and discomfort.
It was determined that anxiety developed on the second day of hospitalization in the intensive care unit, state anxiety was associated with trait anxiety and pain, and anxiety was low in patients receiving mental health care/treatment. And also not to change position himself of patient in prone position due to care equipment etc it can cause loss of self-control and anxiety. Twelve-sixteen hour prone position recommendation for clinical improvement, positioning difficulties in patients who cannot position themselves may also trigger anxiety in awake patients.
Music therapy is applied as a non-pharmacological nursing intervention in the anxiety management of patients in intensive careIt is stated that music therapy is effective in stress-anxiety management, improves vital signs and sleep quality, and may have a muscle relaxant effect in interventions applied in covid-19. It has been suggested that music therapy may be effective in reducing anxiety related to weaning from mechanical ventilation in COVID-19 patients. Music therapy intervention in ICU has been tested in sessions of at least 30 minutes, 1-30 days, with options such as western music, classical Chinese music, nature-based music. It has been reported that music therapy applied with all types of music provides normal heart rate, respiratory recovery and muscle relaxation. Golino et al. listened to music for 30 minutes according to the preferences of the patients in the intensive care unit and their vital signs, pain and anxiety were evaluated. While there was an improvement in heart rate and respiration, oxygen saturations did not change. At the same time, patients reported less pain and anxiety. In the study of Chu and Zhang (2021), it was shown that the recovery time for tomography findings, the number of days of hospital stay and the rates of transfer to the intensive care unit were lower in the patient group who received holistic mode including traditional Chinese medicine, music therapy, and emotional support in COVID-19 patients. Studies evaluating the effectiveness of music therapy alone in the COVID-19 intensive care process could not be reached. It is thought that music therapy applied in the prone position in the COVID-19 intensive care unit will reduce the anxiety of the patients, adapt to the prone position and improve their clinical parameters.
Objective: The aim of this study is to evaluate the effect of music therapy applied in the prone position on anxiety, compliance with the prone position, and vital signs in patients diagnosed with COVID-19 in the intensive care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Therapy, Anxiety, Respiratory Distress Syndrome, Intensive Care Units, Nursing
Keywords
COVID-19, Prone position
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A triple-blind randomized controlled clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music therapy
Arm Type
Experimental
Arm Description
Music therapy intervention, bluetooth headphones will be applied in the intensive care unit and will be disinfected after the application. The intervention consists of a 30-minute, single-session, nature-based music concert. the music concert is calibrated by the audiologist (60 decibels). During nature-based music listening, patients will be asked to close their eyes, rest and follow the sound flow.
Arm Title
control
Arm Type
No Intervention
Arm Description
The control group will be given the prone position and music therapy will not be applied.
Intervention Type
Other
Intervention Name(s)
musıc therapy
Intervention Description
After the prone position was given to the patients, according to the randomization table, the intervention group was given 30 minutes by the nurse. nature-based music therapy will be applied.
Primary Outcome Measure Information:
Title
anxiety
Description
State Anxiety Inventory
Time Frame
change from baseline state anxiety after position change at one day
Title
vital signs
Description
pulse rate
Time Frame
change from baseline pulse rate after position change at one day
Title
vital signs
Description
respiratory rate
Time Frame
change from baseline respiratory rate after position change at one day
Title
vital signs
Description
blood pressure
Time Frame
change from baseline blood pressure after position change at one day
Title
vital signs
Description
oxygen saturation
Time Frame
change from baseline oxygen saturation after position change at one day
Title
prone position adaptation
Description
length of stay in prone position
Time Frame
time/hour to stay in prone position at one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients between the ages of 18-80
Developing respiratory failure due to COVID-19
Prone position applied
Staying in intensive care unit for at least 24 hours
Awake and cooperative
Recipient of oxygen mask or high-flow oxygen therapy or noninvasive mechanical ventilation support
Stable hemodynamic status
Exclusion Criteria:
Those who do not agree to participate in the research
Those with communication barrier problems
Intubated
Sedation drug applied
Those who need emergency intervention during work
Having a diagnosis of neurological and psychological medicine
Abnormal deterioration in physiological parameters
Patients transferred to another service or discharged
patients with hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil İbrahim KARAÇAR, RN
Organizational Affiliation
Antalya Kepez State Hospital Intensive Care Unit
Official's Role
Study Chair
Facility Information:
Facility Name
Antalya Kepez State Hospital Intensive Care Unit
City
Antalya
ZIP/Postal Code
07320
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The decision to share the study results will be made during the study period or when it is concluded.
Citations:
Citation
Bamford, P., Bentley, A., Dean, J., Whitmore, D. & Wilson-Baig, N. ICS guidance for prone positioning of the conscious COVİD-19 patient 2020. London: Intensive Care Society, 2020. (01.10.2020 tarihinde https://emcrit.org/wp-content/uploads/2020/04/2020-04-12-Guidance-for-conscious-proning.pdf adresinden ulaşılmıştır).
Results Reference
background
PubMed Identifier
32748797
Citation
Bastoni D, Poggiali E, Vercelli A, Demichele E, Tinelli V, Iannicelli T, Magnacavallo A. Prone positioning in patients treated with non-invasive ventilation for COVID-19 pneumonia in an Italian emergency department. Emerg Med J. 2020 Sep;37(9):565-566. doi: 10.1136/emermed-2020-209744. Epub 2020 Jul 6.
Results Reference
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33682284
Citation
Chu L, Zhang Y. A study on nursing effect of integrated traditional Chinese and Western medicine management mode on COVID-19. Jpn J Nurs Sci. 2021 Mar 7;18(3):e12411. doi: 10.1111/jjns.12411. Online ahead of print.
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Dwitasari, M. A. D., & Laksmidewi, A. A. A. P. (2020). Convalescent Plasma Therapy in Effort of Weaning from Mechanical Ventilation Using Music Stimulation in Severe COVİD-19 Patients. Open Access Macedonian Journal of Medical Sciences, 8(T1), 192-197.
Results Reference
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PubMed Identifier
32368483
Citation
Elkattawy S, Noori M. A case of improved oxygenation in SARS-CoV-2 positive patient on nasal cannula undergoing prone positioning. Respir Med Case Rep. 2020 May 4;30:101070. doi: 10.1016/j.rmcr.2020.101070. eCollection 2020.
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PubMed Identifier
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Citation
Gibson PG, Qin L, Puah SH. COVID-19 acute respiratory distress syndrome (ARDS): clinical features and differences from typical pre-COVID-19 ARDS. Med J Aust. 2020 Jul;213(2):54-56.e1. doi: 10.5694/mja2.50674. Epub 2020 Jun 22. No abstract available.
Results Reference
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30600227
Citation
Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA. Impact of an Active Music Therapy Intervention on Intensive Care Patients. Am J Crit Care. 2019 Jan;28(1):48-55. doi: 10.4037/ajcc2019792.
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Hunter BC, Oliva R, Sahler OJ, Gaisser D, Salipante DM, Arezina CH. Music therapy as an adjunctive treatment in the management of stress for patients being weaned from mechanical ventilation. J Music Ther. 2010 Fall;47(3):198-219. doi: 10.1093/jmt/47.3.198.
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Latuapo, A., Farid, M., & Ab Rahman, Z. (2020). Pharmaceutıcal and Nonpharmaceutıcal Use Of Musıc and Al-Quran Therapy in Preventıng The Spread Of Pandemıcs (Covıd-19): A Systematıc Revıew. Systematic Reviews in Pharmacy, 11(12), 1171-1179.
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Somagutta, M. R., Pormento, M. K. L., Khan, M. A., Hamdan, A., & Dodla, S. N. (2021). 262: Awake Self Prone Positioning Outcomes in Nonintubated COVİD-19 Patients. Critical Care Medicine, 49(1), 118.
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The Effect of Music Therapy in COVID-19 Patients Given Prone Position
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